Cervical Cancer Vaccine Continues to Spark Debate

Most agree that Gardasil is effective, but should its use be compulsory?

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THURSDAY, March 29, 2007 (HealthDay News) -- As 24 states consider laws that would require girls entering sixth grade to be vaccinated against the cervical cancer-causing human papillomavirus (HPV), the morality behind the move has taken center stage.

However, public health experts note that a medical debate is going on about whether mandating a vaccine for a disease that is not highly contagious is smart or cost-effective.

Some experts support mandating vaccination for all girls, while others support voluntary use of the vaccine. Conservative groups and some parents have also voiced the concern that immunizing girls against HPV -- which is transmitted sexually -- might lead to more premarital sex. Other experts worry that mandating the vaccine, called Gardasil, will open the floodgates to the compulsory use of other shots as they are developed.

Countries elsewhere are also considering widespread use of the vaccine. On Wednesday, Italy became the first European nation to offer the HPV vaccine free to its citizens. Health officials there said they will launch a campaign to encourage the immunization of 12-year-old girls, but the shot will not be mandatory.

Routine, voluntary use of the vaccine in young girls does have the support of most major U.S. medical groups. In fact, on Thursday, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practice formally recommended use of the Gardasil vaccine for girls aged 11 and 12, and for females aged 13 to 26 who have not yet been immunized.

Members of the American Academy of Pediatrics' (AAP) Committee on Infectious Diseases have described the vaccine as safe and effective in preventing cervical cancer, but they also stopped short of recommending mandatory vaccination.

"The vaccine is an important vaccine, and it has the ability to decrease cancer," said Dr. Robert Frenck, a professor of pediatrics at Cincinnati Children's Hospital and a member of the AAP committee.

"My concern is that HPV is a different kind of transmission than diseases we normally look at for mandating vaccines," Frenck said. "Diseases such as measles or chickenpox are transmitted by casual contact. With HPV, it's not a casual contact."

In addition, Frenck believes there will be significant economic consequences for states if the HPV vaccine is mandated. Pending bills that mandate the vaccine have provisions for the state to pay for immunization, he noted. That could turn out to be very expensive.

"Right now, the three-dose series is approximately $120 a dose -- that's $360 for the full series," he said. Without extra funds, the cost of the vaccine would strain already overburdened public health systems, he said.

Another expert is also against mandating the vaccine, but this time for medical reasons.

"The vaccine is too new to be thinking about mandates," said Dr. Jon Abramson, a professor of infectious diseases at Wake Forest University Medical School and chairman of the CDC's immunization practices committee.

His committee doesn't consider recommending mandating a vaccine until it has been available for a long period of time, so that they can properly judge the demand, Abramson said. "We never discussed mandates, because it was way too early," he noted.

Because HPV is sexually transmitted, it also doesn't present the same risk as diseases that are transmitted by more casual contact, he added. "Most of the things we have mandates for are things that are high-risk in a school setting," Abramson said. "If someone walks into a school with measles, it's going to rapidly spread to those who aren't protected. Hopefully, you are at lower risk for HPV in school."

Money is also an issue. "I am very opposed to kids being kicked out of school, because parents can't afford the vaccine, and states can't pay for it," he said.

Finally, most state-proposed mandates include an easy way for parents to waive the HPV vaccine requirement. That worries Abramson, because it might make it easier for parents to opt out of other mandated vaccines, as well. "That will harm our other vaccines," he said.

Mandates aside, Abramson said he does support young girls being voluntarily vaccinated against cervical cancer. "My two daughters have already gotten their first dose," he said.

Because the vaccine is only effective before someone is exposed to HPV, girls should start being vaccinated when they are 11 or 12, Abramson said. "The reason for that is that there was data presented to us [on the CDC advisory committee] that showed that by the time kids enter ninth grade, 25 percent of males and females are sexually active," he said.

Despite some public opposition to mandates, many medical professionals feel strongly that the vaccine should be mandated, because it can prevent up to 70 percent of cervical cancers.

"HPV is responsible for a significant amount of morbidity and mortality related to venereal warts and to the development of pre-invasive and invasive cancer of the cervix," said Dr. Ralph Anderson, chairman of obstetrics and gynecology at the University of North Texas Health Center.

There are about 10,000 new cases of cervical cancer diagnosed in the United States each year, and about 4,000 women die of cervical cancer each year, Anderson noted.

"If the vaccine was given universally, it would eliminate about 90 percent of the venereal warts, and it would eliminate about 70 percent of the cases of cancer of the cervix," Anderson said. "About 30 percent of the types of cervical cancers are caused by one of the types of HPV not represented in the vaccine."

To those who think that money is an issue in mandating the vaccine, Anderson said they need to prove that it costs more to vaccinate girls than to treat them for cervical cancer later in life.

"It costs $300 to get the vaccine. If you get cancer of the cervix, it will probably cost $100,000 to treat it, and then a lot of those people die," he said. "Show me that it's more expensive to give the vaccine than not give the vaccine. The cost concern is a smokescreen."

Anderson believes Gardasil will go a long way to stemming the current "epidemic" of HPV infection. "In their lifetime, 75 percent of U.S. women will be exposed to the HPV virus. At any one time, about 25 percent have been infected with the virus," he said. "If that's not epidemic proportions, I don't know what is."

Not all the objections to mandating the vaccine are medical. Others have voiced political and moral objections.

"It's an end run around parental rights," said Wendy Wright, president of Concerned Women for America, a conservative lobbying group. "Parents know what's best for their daughters. Even with an opt-out option, it puts the parents in a position where they have to justify themselves to government officials," she said.

Wright also objects to the vaccine, because it has not been proved to be safe for the general population. "It could be putting people at risk with the assumption that since the government approved it, and it's being mandated by the states, it must be safe," she said. "But they really can't say that for certain."

She also questioned the need for Gardasil in the first place. According to Wright, the threat of cervical cancer has diminished significantly with the use of regular Pap smears and more effective treatment.

HPV is sexually transmitted, so Wright believes there's a clear way to avoid it: Practice abstinence. "The best prevention is being sexually responsible," she said. "That means being abstinent outside of marriage and faithful inside of marriage."

In addition, women should continue to get regular Pap tests as recommended, she said. "The vaccine should be a third option," Wright said.

Strong negative reaction from some segments of the public to state mandates caused pharmaceutical giant Merck, which makes the vaccine, to pull back on lobbying efforts advocating mandated vaccination. Repeated calls to Merck for comment were not returned.

Wright is also concerned that mandating the vaccine will lead to mandates for other vaccines. "That's what happened with the hepatitis B vaccine," she said. "It kind of slipped through in the early 1990s. The public health community rammed that through."

Abramson agreed that vaccines for other cancers should not be mandated. Mandated vaccines should be limited to those diseases that are highly contagious and spread by casual contact, he said. "Right now, I am not willing to cross that line," he said.